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MHA Home > About MHA > Biomedical Waste

About MHA

Biomedical Waste Service

The Maine Hospital Association, in conjunction with SteriLogicME and Hydroclave Systems Corp, has been busy at work completing your AHR Medwaste Treatment Plant located in Pittsfield. The plant became fully operational June 23rd.

While there will be minor changes to the routing schedule, the only substantial difference in your medwaste service has been the switch from cardboard boxes to reusable tubs. Please review the information below and if you are in need of further information, please contact our offices at your earliest convenience.

REUSABLE MEDWASTE TUBS

As most of you are aware, this operation will be utilizing reusable plastic medwaste tubs in lieu of cardboard boxes for all medwaste with the exception of 'bypass waste' (trace chemo, cytotoxic, pharmaceutical and pathological wastes), resulting in significant waste volume reductions for your facility. The tubs are 38-gallon and 28-gallon in size.

While the MHA will be providing the tubs at no cost to you, the following link has various components and products that can beused with these tubs (such as dollies, automatic lids, etc.). Please feel free to order directly from Solutions, Inc. if you desire any of these add-ons.

Website: www.a-solutionsinc.com
Product: 38-gallon container #SI-138R
28-gallon container #SI-128R

These tubs are not designed to be distributed throughout hospitals. They are specifically for handling medical waste and, as such, may not be suitable for introduction directly into procedure rooms, etc. There is also a significant amount of inventory control required to assure that all hospitals have sufficient quantities to handle their needs. Having excessive quantities of tubs unutilized at hospitals can pose shortage problems when system-wide inefficiencies are taken into consideration. SteriLogicME will work with hospitals to make this inventory flow suitable for all parties.

SteriLogicME performs all tub washing and disinfecting onsite including QC of each and every container. Be assured that it is in SteriLogicME's best interest to provide containers that will meet the strict requirements of your facility's infection control departments. Furthermore, you will have the opportunity (ay any time) to inspect the operation and comment on protocols.

Please note: while tubs do not require liners, ALL WASTE CONTENTS MUST BE BAGGED.

OVERSIZED MEDWASTE ITEMS

SteriLogicME will also utilize 96- and 200-gallon carts for any wastes (such as large sharps containers) that do not fit inside the supplied tubs. Each collection truck will have at least one of these large carts on it for this purpose. Such items must be individually labeled (in accordance to packing requirements) and SteriLogicME will include these items on the manifest upon pick-up.

WASTE SEGREGATION

One significant benefit of utilizing the Hydroclave waste sterilization system is that medical waste generators can physically see the various wastes being processed. This allows employees to clearly review the waste segregation protocols and help mitigate their medical waste stream through proper segregation. Attached to this document are the Maine DEP Chapter 900 regulations explaining medical waste handling requirements.

To avoid DOT violations and potentially hazardous working conditions, AHR will assess a charge for improperly segregated wastes. The fee during the remainder of 2005 will be a $40.00 repackaging fee for each wrongly segregated and/or improperly packaged container, plus any costs associated with correcting issues arising from improper segregation (such as testing or clean-up). In any instance where the plant has to be temporarily shut down because of potential hazardous conditions due to improper segregation, a fee of $250 per hour will be assessed during the temporary shut-down.

Beyond the Chapter 900 regulations, there are some specific items that are not conducive to the systemic design of the Hydroclave equipment and the required shredding component of the operation.

Below is an outline of frequently mis-segregated items, as well as items that must be incinerated due to processing constraints:

Items not classified at Biomedical Waste - see Section 7.A.(2) in Chapter 900 regulations:

(1) Disposable gowns, linens (unless saturated with blood or from an isolation room).
- For many facilities, disposable gowns and linens can represent as much as 50% of the total volume of waste (not weight). Aside from requiring significant storage and high transportation costs, the handling of this waste is costly for hospitals and difficult to processor in the Hydroclaves. If you would like an audit of this waste specific to your facility, SteriLogicME will be happy to provide you with one.
(2) Reusable linens, scrubs
- These items can be laundered and reused.

Items requiring incineration by Chapter 900 regulations:

(1) Chemotherapeutic Waste
(2) Cytotoxic Waste
(3) Pharmaceutical Waste
(4) Isolation Room Waste (which must be clearly labeled)
(5) Pathological Waste

Items requiring incineration by plant operating requirements:

(1) Surgical wires and tubing
(2) Large steel instruments
(3) Fixing Agents (which are highly corrosive)
(4) Titanium hips (and other solid steel items)

Attached is a chart showing basic medwaste segregation information. Note that trace chemical wastes (chemotherapeutic, cytotoxic, antineoplastic) and trace radioactive waste are considered by-pass waste (meaning it can be transferred at our plant and shipped to an incinerator) and can be handled by SteriLogicME. Bulk volumes of this waste (such as liquid forms) must be handled as HAZARDOUS WASTE by a separate contractor, as the AHR facility is not licensed for transfer of hazardous waste - only biomedical waste. For a list of HazMat contractors, please call SteriLogicME.

Sharps waste (except trace chemo) is NOT by-pass waste and DOES NOT require incineration. The AHR plant will treat and destroy sharps waste (through shredding), and this waste should be placed in a sharps container and then in the reusable medwaste tubs.

Information Web Links:

Hospitals for a Healthy Environment: http://www.h2e-online.org/pubs/wrguide/section7.pdf
Maine DEP Div of Waste Mgmt: http://www.maine.gov/dep/rwm/biomedical/index.htm
and http://mainegov-images.informe.org/dep/rwm/biomedical/pdf/ipbiomedicalwasterules.pdf

BYPASS WASTES

As many of you are aware, by-pass wastes (namely chemotherapeutic and pathological wastes) represent a significant portion of the medwaste stream generated in this state - on average 8.6% of the total medwaste volumes in Maine. (Nationally, this waste stream is closer to 5%.) This waste stream cannot be processed in the AHR facility and, by law, has to be incinerated. As more and more incinerators are shut down in the United States, disposal options close with them. At this point, all by-pass waste has to be shipped as far away as North Carolina - at significant transporting cost.

For this reason it is imperative to properly segregate your by-pass waste from the regular medwaste. We ask that you do not 'top off' boxes of by-pass waste with medwaste, as this only exacerbates the problem. We need as many pounds of waste to be processed in our own facility as possible, as the by-pass waste is processed at significant cost by the pound. Please see the chart below for proper segregation procedures.

Generators will continue to be supplied cardboard boxes and liners for the by-pass waste. Generators will initially be charged for the supplies, but upon receipt of the filled boxes, be reimbursed the supply charge. This will apply only to member hospitals; small generators (as detailed below) will not be reimbursed for supplies. The fees for 2005 are: $1.50 per 4.5 CF box, $1.25 per 2.5 CF box and $0.35 per liner and will be billed upon delivery. Generators will be credited one box and one liner for each box received by SteriLogicME.

SMALL GENERATORS

Many hospitals receive medwaste packages from nearby doctors, dentists, veterinarians, etc. For those hospitals that wish to pare off this service, now that the plant is fully permitted SteriLogicME has begun servicing these types of accounts with a pre-negotiated preferential price.

If you wish to continue this receiving service you may do so, but several issues must be addressed:

(1) Reusable medwaste tubs are for member hospitals ONLY. These tubs are expensive and it is not cost effective to use them in areas that don't 'turn' them over quickly. Cardboard boxes should be distributed for this purpose.
(2) SteriLogicME will supply cardboard boxes for distribution to small generators; however, as these boxes are not free to us, we will have to assess a charge for packing supplies. This fee will be $1.50 per 4.5 CF box, $1.25 per 2.5 CF box and $0.35 per liner and will be billed upon delivery, as noted above.
(3) Be sure that your facility is not receiving any single waste delivery (from one generator) in excess of 50 lbs unless you are a DEP permitted biomedical waste transfer facility.
(4) Be sure to keep a log of all waste received, or manifests if required.

If you wish to have SteriLogicME service these small generators, please fax a copy of the contact information for the generators to our office and we will take care of the rest. For pricing information, please contact our office and we will fax you a copy of the rate schedule approved by MHA.

"PRODUCTS OF CONCEPTION"

In any instance where a generator requires the delicate handling of certain human remains, we have negotiated cremation services through a crematory in Auburn, ME. We will provide this service using a per-box or per-lb fee. Please call SteriLogicME for more information.

SITE VISITS / HOSPITAL IN-SERVICE

As members of the MHA and owners of this newly built plant, you will have the opportunity at any time to stop in for a site visit. Please call in advance if you need to meet with a manager or would like a tour of the operation.

SteriLogicME employees will also perform in-serve assistance at your facility to go over proper segregation protocol and to assist your facility in waste reduction programs.


REUSABLE SHARPS CONTAINERS

For those electing to trial the reusable sharps container program, we will are currently able to service large sharps containers (10 and 17-gallon containers). We expect to be able to service smaller sharps containers by mid-August.

A SteriLogicME representative will be pleased to meet with your managers, perform savings analyses and discuss safety issues. Typically, a trial is performed in each facility prior to facility adoption, during which time employees share their concerns regarding the program.

For those desiring further information on this program, please contact SteriLogicME's General Manager.




 

Solid Medical Waste Disposal Procedures


SHARPS
CONTAINER*

MEDWASTE
TUB

PATHOLOGICAL WASTE
TRACE CHEMO/ CYTOTOXIC/ RADIOACTIVE

BULK CHEMO/ CHEMICAL/ RADIOACTIVE

Uncontaminated1 or Contaminated only with biohazardous waste2:

  • Needles
  • Needles w/syringes
  • Needles w/attached tubing
  • Blades (razors, scalpels)

Contaminated only with biohazardous waste:

  • Broken glass
  • Pasteur and other pipettes
  • Microscope slides
  • Other contaminated sharps items

Uncontaminated or Contaminated only with biohazardous waste:

  • Plastic syringes w/out needles
  • *Full DISPOSABLE sharps containers


Contaminated only with biohazardous waste:

  • Anything contaminated with biohazardous waste (in the case of linens and gowns - saturated with blood) that does not go into a sharps container or a pathology container

Uncontaminated or Contaminated only with biohazardous waste:

  • Large tissue specimens
  • Other recognizable human body parts and tissues

Uncontaminated or contaminated:

  • Sharps must be placed in YELLOW chemo sharps container.

Uncontaminated or contaminated:

  • Chemo, cytotoxic or chemical waste in liquid or bulk form
  • Radioactive waste
  • Antineoplastic waste
Disposal:
If sharps container is disposable, dispose in reusable medwaste tub; if sharps container is reusable, place unpackaged in medwaste storage area.
Disposal:
Close the red biohazard bag. Dispose bag into a reusable medwaste tub. Note: a liner is not needed in reusable tubs
Disposal:
Close the red biohazard bag. Keep the bag in a red container (or freezer until pickup time). Place yellow "incinerate" or "pathological" sticker on box.
Disposal:
Place first in yellow plastic bag, then in cardboard box with liner. Place yellow "incinerate" or "chemo waste" sticker on box.

Disposal:
This is Hazardous Waste and is NOT part of the medwaste stream. This waste is handled by a different contractor.


1 Uncontaminated means there is no biohazardous, chemical or radioactive contamination.
2 Biohazardous waste includes the following: primary human cell lines and tissue cultures; organisms with recombinant DNA; cultures and stocks of infectious agents; potentially infectious bacteria, viruses, and spores; toxins; live and attenuated vaccines; blood and blood products. If your biohazardous waste is also contaminated with chemical and/or radioactive materials, DO NOT dispose as medical waste.


IF YOU ARE UNSURE HOW TO DISPOSE OF MEDICAL WASTE, CONTACT SteriLogicME (207) 487-5300

CONTACT INFORMATION


Associated Health Resources - Facility Owner
(a subsidiary of the Maine Hospital Assoc.)
33 Fuller Road
Augusta, ME 04330
Tel: (207) 622-4794
Fax: (207) 622-3073
Contact: Tamara Butts
Email: tbutts@theMHA.org

SteriLogicME, Inc. - Operator
(a subsidiary of SteriLogic Waste Systems, Inc.)
82 Industrial Park Road
Pittsfield, ME 04967
Tel: (207) 487-5300
Fax: (207) 487-5333
Contact: Mike McIntyre, General Manager
Email: mcintyre@sterilogic.com


Hydroclave Systems Corp - Plant Designer
672 Norris Court
Kingston, Ontario, Canada K7P-2R9
Tel: (613) 389-8373
Fax: (613) 389-8554
Contact: Richard Vanderwal, President
Email: rvanderwal@hydroclave.com



PACKAGING & HANDLING

REUSABLE TUBS - GENERAL INSTRUCTIONS

NOTE: REUSABLE TUBS ARE FOR BIOMEDICAL WASTE ONLY. All other waste, such as cytotoxic, chemo and patho waste must be packaging in cardboard boxes, as detailed below.

As part of the overall biomedical waste plan set forth by the Maine Hospital Association, waste stream mitigation became an important part of the long-term strategy relating to the economic benefits of the management plan. As such, the MHA selected to implement reusable biomedical-waste tubs in order to aid in the reduction of wastes generated throughout the state. By implementing these reusable tubs, generators can expect a biomedical waste stream reduction of roughly 10% due to the elimination of cardboard waste. Each cardboard box weighs roughly 2.6 lbs and is included in the waste weight applicable to your destruction fee. Presuming a destruction fee of $0.30 per lb, this equals $0.78 per box just to dispose of the box. Furthermore, the box and liner cost (typically about $1.41) is eliminated permanently.

The only weight limit to each tub is a 52-pound Maine-regulated maximum (pertaining to total weight that can be lifted repetitively by a single person). The average weight of these containers is 30-35 lbs, and will vary with contents.

While the reusable tubs do not need a specific liner, all waste contents must be bagged in red-bags as noted in "A. Packaging" in Chapter 900 of the DEP regulations (see summary below). Once emptied at the treatment plant, each tub will be washed, disinfected and dried prior to redistribution (in accordance to Chapter 900 Section 12.A (7) & (8)).

All reusable tubs nest and stack. Tubs will be delivered in accordance to overall volume and need. Tubs are not designed to be distributed throughout hospital facilities as point-of-use disposal mechanisms (a.k.a. waste cans), though some facilities may use this practice and we will work with you to make sure this remains economical for both your facility and the MHA (as it pertains to tub inventory control).

Reusable tubs must be labeled immediately after packaging according to Chapter 900, Section 12(A)(6). The label shall be securely attached to the outer layer of packaging and be clearly legible. Indelible ink shall be used to complete the information on the label, and the label shall be at least three inches by five inches in size. The following information must be on the label:

(1) The name, address, business telephone number, and registration number of the generator;
(2) "Biomedical Waste" or "Infectious Waste" in large print;
(3) "Refrigeration Required", in large print if pathological waste, cultures, or body parts are included in the contents;
(4) The name, address, business telephone number, and registration number of the person or persons to whose control the biomedical waste is to be transferred;
(5) The international biohazard symbol; and
(6) The date upon which the biomedical waste was packaged in accordance with Section 12(A)(6).

SteriLogic will provide labels for each hospital, including much of the information noted above. Individuals responsible for sealing each container shall assure that the remaining information is entered and accurate.



DISCARDED SHARPS

Discarded sharps shall be segregated from other biomedical waste at the point of generation. Discarded sharps shall be placed directly into leak-resistant, rigid, puncture-resistant containers without clipping or breaking. These containers shall be taped closed or tightly lidded to preclude loss or leakage of contents. After proper packaging, sharps containers may be placed in biomedical waste bags referred to in Chapter 900 Section 12 (A)(1).

REUSABLE SHARPS CONTAINERS

The reusable sharps containers supplied by SteriLogicME are DOT approved for transport and do not require any additional packaging. DO NOT place these containers inside a reusable tub or cardboard box. DO NOT utilize reusable sharps containers for any waste that requires incineration. Simply place full sharps containers in the medwaste collection room, label them in the same fashion as other medwaste containers and SteriLogicME personnel will handle the rest.

CARDBOARD BOXES - GENERAL INSTRUCTIONS

  • Only use containers that meet UN 3291 Packaging Group II criteria and are US DOT-approved. (All containers supplied by SteriLogic meet these criteria.)

 

  • All bags containing biomedical waste shall be red in color and imprinted with the international biohazard symbol and the words "biomedical waste" or "infectious waste."

 

  • Cardboard boxes must:

o Have a plastic bag liner inserted into the box prior to accepting waste;

o Be sealed with tape on all seams prior to shipment;

o Be labeled and dated immediately after packaging according to Chapter 900, Section 12(A)(6). Note: Unlabeled containers cannot be picked up by SteriLogic employees. The label shall be securely attached to the outer layer of packaging and be clearly legible. Indelible ink shall be used to complete the information on the label, and the label shall be at least three inches by five inches in size. The following information shall be included on the label:

(1) The name, address, business telephone number, and registration number of the generator;
(2) "Biomedical Waste" or "Infectious Waste" in large print;
(3) "Refrigeration Required", in large print if pathological waste, cultures, or animal carcasses or body parts are included in the contents;
(4) The name, address, business telephone number, and registration number of the person or persons to whose control the biomedical waste is to be transferred;
(5) The international biohazard symbol; and
(6) The date upon which the biomedical waste was packaged in accordance with Section 12(A)(6).

" Total weight per box may not exceed 55 lbs.


REGULATIONS - MAINE DEP CHAPTER 900
BIOMEDICAL WASTE MGMT RULES (EXCERPTS)


6. Definitions

A. Antineoplastic drug. "Antineoplastic drug" means any of the group of cytotoxic drugs used in the treatment of cancer.

B. Biologicals. "Biologicals" means preparations made from living organisms and their products, including serums, vaccines, antigens, and antitoxins.

C. Biomedical waste. "Biomedical waste" means a waste that may contain human pathogens of sufficient virulence and in sufficient concentrations that exposure to it by a susceptible host could result in disease. Biomedical waste is further defined in Section 7 of this rule.

D. Biomedical waste activity. "Biomedical waste activity" means the generation, handling, storage, transport, treatment, or disposal of biomedical waste.

E. Biomedical waste manifest. "Biomedical waste manifest" means the form used for identifying the quantity, composition, and the origin, routing, and destination of biomedical waste during its transportation from the point of generation to the point of off-site treatment, or disposal.

G. Chemotherapy waste. "Chemotherapy waste" means all materials that have come in contact with and have no more than trace amounts of cytotoxic/antineoplastic agents.

I. Contaminated. "Contaminated" means soiled or made inferior or potentially infectious through physical contact or mixture with a biomedical waste.

K. Cytotoxic drugs. "Cytotoxic drugs" means drugs that are toxic to living cells.

M. Discharge. "Discharge" means any spilling, leaking, pumping, pouring, emitting, emptying or dumping.

N. Disinfect. "Disinfect" means to reduce the infectiousness of an object or material such that it poses virtually no risk of infection to those handling, or otherwise coming into contact with, the object or material.

R. Generator. "Generator" means any person or medical facility whose act or process produces biomedical waste in any quantity.

S. Handle. "Handle" means to store, transfer, collect, separate, salvage, process, reduce, recover, incinerate, treat or dispose of.

T. Hazardous waste. "Hazardous waste" means material that is identified as hazardous waste under Chapter 850 of the Department's Hazardous Waste Management Rules.

W. Infectious. "Infectious" means caused by or capable of being communicated by invasion and multiplication of microorganisms in body tissues; having the potential to transmit disease.

X. Infectious agent. "Infectious agent" means a biological substance (such as a virus, bacterium or other biological organism) capable of causing disease or adverse health impacts in humans.

Y. Medical facility. "Medical facility" means any place where biomedical waste is generated, including, but not limited to: hospitals, ambulatory surgical centers, emergency medical service providers, offices and mobile units of health care providers including doctors and dentists, nursing homes, medical diagnostic laboratories, blood centers, pharmaceutical companies, research laboratories, health agencies, diet or health care clinics, offices of veterinarians, veterinary hospitals, and funeral homes and mortuaries.

BB. Off-Site. "Off-Site" describes a facility or area for the storage, handling, treatment, and/or disposal of biomedical waste which is not on the generator's site (i.e., "on-site") or a facility or area which receives biomedical waste for storage or treatment which has not been generated "on site" at that facility.

CC. On-Site. "On-Site" describes the land area and appurtenances thereon and thereto used for the collection, storage, handling, treatment, and/or disposal of biomedical waste on the same or geographically contiguous property at which biomedical waste is generated. Two or more pieces of property which are geographically contiguous but which are divided by public or private right(s)-of-way are a single site for the purposes of this rule.

DD. Operator. "Operator" means any person who has care, charge or control of a biomedical waste facility or conveyance subject to these rules. This person may be an agent, a lessee of the owner, or an independent contractor.

FF. Pathological waste. "Pathological waste" means human tissues, organs, and anatomical parts including teeth, discarded from surgery, autopsy, obstetrical procedures, and laboratory procedures.

HH. Radioactive waste. "Radioactive waste" means any waste material which emits ionizing radiation spontaneously.

II. Saturated. "Saturated" means thoroughly soaked or dripping. For the purposes of this rule the term "saturated" refers to a waste, which at the time of generation, is soaked or dripping with human blood, blood products or body fluids.

JJ. Sharps. "Sharps" means items which may cause puncture wounds or cuts including, but not limited to, hypodermic needles, syringes, scalpel blades, capillary tubes and lancets. Sharps are further identified in Section 7(A)(4) of this rule.

KK. Site. "Site" means the same or geographically contiguous property which may be divided by a public or private right-of-way, provided that the entrance and exit between the properties is at a crossroads intersection and access is by crossing as opposed to going along the right-of-way. Noncontiguous properties owned by the same person but connected by a right-of-way which he controls and to which the public does not have access is also considered site property.

LL. Site Location Law. "Site location Law" means the Site Location of Development Law, 38 M.R.S.A., Sec. 481, et seq.

MM. Solid-waste. "Solid waste" as defined in 38 M.R.S.A., Sec. 1303-C (29) means useless, unwanted or discarded solid material with insufficient liquid content to be free flowing, including by way of example, and not by limitation to, rubbish, garbage, scrap materials, junk, refuse, inert fill material, and landscape refuse. The term does not include septage or agricultural wastes.

NN. Special waste. "Special waste" as defined in 38 M.R.S.A., Section 1303-C (34) means any nonhazardous waste generated by sources other than domestic and typical commercial establishments that exists in such an unusual quantity or in such a chemical or physical state, or any combination thereof, which may disrupt or impair effective waste management or threaten the public health, human safety or the environment and requires special handling, transportation and disposal procedures.

OO. Storage. "Storage" means the containment of biomedical waste either on a temporary basis or for a period of years, in such a manner as not to constitute disposal of such wastes.

PP. Substantial modification. "Substantial modification" means any change in size, volume handled or operation of a licensed facility which may pose a risk to health, safety, welfare or the environment which is significantly different in kind or degree from that posed by the facility without the modification, or may pose a significant risk which was not considered in the original application or is not addressed in the existing license.

QQ. Transfer facility. "Transfer facility" means any transportation-related facility including loading docks, parking areas, storage areas and other similar areas where shipments of biomedical waste are held during the normal course of transportation.

RR. Transport. "Transport" means the movement of biomedical waste from the point of its generation to any intermediate points and finally to its point of ultimate disposition. Movement of biomedical waste on the site where it is generated or on the site of a licensed biomedical waste facility is not "transport."

SS. Transporter. "Transporter" means any person who transports biomedical waste in this state in any quantity except as provided for in Sections 4(B) and 4(C) of this rule. The term includes, without limitation, individuals who own, lease or otherwise control conveyances in which biomedical waste is transported, operators of such conveyances, and businesses regardless of size and form of business organization, which engage in transportation of biomedical waste.

TT. Treatment. "Treatment" means any method, technique, or process designed to change the biological character or composition of biomedical waste so as to eliminate or reduce its potential for causing disease.


7. Definition of Biomedical Waste

A. Identification of Biomedical Waste. The following wastes may contain human pathogens of sufficient virulence and in sufficient concentrations that exposure to them by a susceptible host could result in disease and are, therefore, biomedical wastes for the purposes of this rule.

(1) Discarded Human Blood, Blood Products, and Body Fluids: Discarded blood, serum, plasma, blood products, and body fluids. Body-fluids are defined as fluids which are generated or removed during surgery, autopsy, obstetrics, emergency care, or embalming and include cerebrospinal fluid, synovial fluid, pleural fluid; peritonea fluid, pericardial fluid and amniotic fluid.

(2) Waste Saturated With Human Blood, Blood Products, or Body Fluids: These may include items such as sponges, surgical gloves and masks, drapes, aprons, dressings, disposable sheets and towels, underpads, plastic tubing, and dialysis unit waste.

NOTE: The intent is to include waste which at the time of generation is soaked or dripping with human blood, blood products or body fluids. An example of material which may be included is a first change surgical dressing.

(3) Pathological Waste: Human tissues, organs, and anatomical parts including teeth, discarded from surgery, autopsy, obstetrical procedures, and laboratory procedures.

(4) Discarded Sharps Used In Patient, Animal, Cadaver Care or In Medical and Biomedical Research Laboratories: These include, but are not limited to, hypodermic needles, syringes, scalpel blades, suture needles, disposable razors, lancets, capillary tubes, Pasteur pipettes, broken glassware, IV tubing with needles attached, and dialysis bags with needles attached.

(5) Discarded cultures and stocks of infectious agents and the culture dishes and devices used to transfer, inoculate and mix cultures; discarded clinical specimens and the associated containers or vials; discarded biologicals; and waste from the production of biologicals and recombinant DNA research.

(6) Discarded Carcasses, Body Parts, Bedding and 0ther Waste Generated By Research Facilities From Animals Containing Organisms or Agents Not Usual To The Normal Animal Environment And Which Are Pathogenic or Hazardous to Humans.

B. Cytotoxic Drugs, Chemotherapy Waste. The following wastes may be managed as biomedical waste for the purpose of this rule:

(1) Cytotoxic (antineoplastic) drugs not identified as hazardous wastes in Chapter 850 of the Department's regulations.

(2) Chemotherapy waste - All materials that have come in contact with, and have no more than trace amounts of, cytotoxic (antineoplastic) agents.

C. Exclusions. The following wastes are not biomedical waste for the purpose of this rule:

(1) Human remains. Human remains that are stored, transported or otherwise handled for the purpose of internment or cremation are not subject to the requirements of this rule.

(2) Urine and feces.

(3) Sludge and septage. Sludge means the semi-solid or liquid residual generated from a municipal, commercial or industrial wastewater treatment plant. Septage means waste, refuse, effluent, sludge and any other materials from septic tanks, cesspools, or any other similar facilities.

(4) Water and wastewater samples. Wastes generated as a result of the routine screening of environmental samples of water and wastewater are not subject to the requirements of this rule.

8. Reference to Other Regulations.

A. Solid waste as defined in 38 M.R.S.A. Section 1303-C (29) and in Section 6 of this rule shall be managed in accordance with the Department's Solid Waste Management Rules, Chapters 400 409.

NOTE: Incinerator ash, provided it is not hazardous by characteristic, is a special waste. Regulations governing the handling, storage and disposal of incinerator ash are specified in Chapter 405 of the Department's Solid Waste Management Rules. Incinerator ash which meets hazardous waste characteristics, as defined in Chapter 850 of the Department's Hazardous Waste Management Rules, shall be managed as a hazardous waste.

B. Hazardous wastes as defined in 38 M.R.S.A. Section 1303-C(15) (with the exception of infectious and pathogenic wastes) and in Chapter 850 of the Department's rules shall be managed in accordance with the Department's Hazardous Waste Management Rules, Chapters 850, 851, 853-857.

NOTE: Some cytotoxic (antineoplastic) drugs are identified as hazardous waste in Chapter 850 of the Department's Hazardous Waste Management Rules.

C. Radioactive wastes as defined in Section 6(HH) of this rule shall be managed in accordance with the rules of the U.S. Nuclear Regulatory Commission and the State of Maine Rules Relating to Radiation Protection.

9. Prohibitions

A. A biomedical waste shall not be mixed with hazardous wastes (other than infectious or pathogenic) or radioactive waste.

B. Where a biomedical waste has been inadvertently or intentionally mixed with hazardous wastes (other than infectious or pathogenic) or radioactive waste, all appropriate rules shall apply to the management of the mixed waste. In instances where there is a conflict between the requirements of the rules, the more stringent requirement shall apply.

NOTE: For example, if biomedical waste is mixed with hazardous waste both the Biomedical Waste Management Rules and the Hazardous Waste Management Rules would apply to the management of the waste.

11. Registration of Generators

A. Registration

(1) Each medical facility which generates a biomedical waste shall register with the Department on forms available from the Department. Facilities generating biomedical waste at the time the rules are adopted by the Board or which commence generation after adoption but prior to the effective date of the rule shall register with the Department by the effective date. Facilities that commence generation of biomedical waste after the effective date of the rule shall register with the Department at least 30 days prior to the date such generation is expected to commence.

(2) The Department will assign a biomedical waste generator registration number to each medical facility which registers with the Department and will notify each such facility in writing of such assigned registration number. Upon receiving such notification, the facility shall include the assigned registration number in or on manifests, labels affixed to packages of biomedical waste, and tags enclosed in each package of biomedical waste.

(3) Facilities which generate biomedical waste shall notify the Department in writing within 30 days of a change in majority ownership, name, location or operational status of the facility.

(4) The registration numbers assigned under this subsection are not transferable.

(5) The registration fee shall be a one-time fee of fifty dollars ($50.00) per facility.

B. Biomedical Waste Management Plan

(1) Except as provided for in Section 4(C) of this rule, each facility which generates biomedical waste shall prepare a written biomedical waste management plan appropriate for the size and type of facility. Such plan shall set forth policies and procedures consistent with these regulations for managing biomedical waste.

(2) The biomedical waste management plan shall include, at a minimum, the following:

(a) a description of the biomedical waste generated by the facility including type and volume of biomedical waste;

(b) a description of any biomedical waste handling procedures, in addition to those required by this rule, which are specific to that facility including such information as location of storage area, etc.;

(c) the treatment/disposal methods for each type of biomedical waste;

(d) personnel training procedures;

(e) spill containment and cleanup procedures and equipment; and

(f) the name, address, and telephone number of the person(s) responsible for biomedical waste management at the facility.

(3) The facility shall certify, at the time of registration, that a biomedical waste management plan has been developed for the facility.

(4) The facility biomedical waste management plan shall be available for inspection by a public safety officer or authorized representative of the Department.

12. Standards for Generators

A. Packaging. Biomedical waste shall be properly packaged to assure effective containment throughout the handling, storage, transport, treatment, and disposal processes.

(1) Biomedical wastes, other than sharps and bulk liquids, shall be packaged in bags which are impervious to moisture and have strength sufficient to resist ripping, tearing or bursting under normal conditions of usage and handling.

(2) All bags containing biomedical waste shall be red in color and imprinted with the international biohazard symbol and the words "biomedical waste" or "infectious waste." Waste in red bags shall be considered biomedical waste and shall be managed as biomedical waste.

(3) Bags shall be sealed by forming a secure closure which results in a leak-resistant seal.

(4) Discarded sharps shall be segregated from other biomedical waste at the point of generation. Discarded sharps shall be placed directly into leak-resistant, rigid, puncture-resistant containers without clipping or breaking. These containers shall be taped closed or tightly lidded to preclude loss or leakage of contents. After proper packaging, sharps containers may be placed in biomedical waste bags referred to in Section 12 (A)(1) of these rules.

(5) Discarded bulk blood and other liquids which is to be transported off-site shall be packaged in tightly stoppered, unbreakable flasks or bottles.

(6) All biomedical waste bagged in accordance with Section 12(A)(3), sharps containerized in accordance with Section 12(A)(4), and bulk liquids containerized in accordance with Section l2(A)(5) which are to be transported off-site shall also be packaged for storage or handling by placement in disposable corrugated fiberboard boxes or equivalent rigid containers such as reusable pails, cartons, drums, or portable bins. The box or container shall be leak-resistant or lined with a bag which is impervious to moisture and has 200-pound burst strength as measured by the industry's Mullen test.

(7) Reusable containers used for the handling of biomedical waste shall be thoroughly washed and disinfected each time they are emptied unless the surfaces of the containers have been effectively protected from contamination by disposable liners, bags or other devices which are removed and disposed of with the waste.

NOTE: A red bag may not be enclosed in a bag of another color.

(8) Reusable containers used for the handling of biomedical waste shall not be used for containment of waste to be disposed of as non-biomedical waste or for any other purpose except after being disinfected.

B. Labeling. Biomedical waste to be transported off-site shall be labeled immediately after packaging in accordance with Section 12(A)(6). The label shall be securely attached to the outer layer of packaging and be clearly legible. Indelible ink shall be used to complete the information on the label, and the label shall be at least three inches by five inches in size. The following information shall be included on the label:

(1) The name, address, business telephone number, and registration number of the generator;

(2) "Biomedical Waste" or "Infectious Waste" in large print;

(3) "Refrigeration Required", in large print if pathological waste, cultures, or animal carcasses or body parts are included in the contents;

(4) The name, address, business telephone number, and registration number of the person or persons to whose control the biomedical waste is to be transferred;

(5) The international biohazard symbol; and

(6) The date upon which the biomedical waste was packaged in accordance with Section 12(A)(6).

C. Handling

(1) Packages of biomedical waste shall be handled in a manner that does not impair the integrity of the packaging.

(2) Trash chutes shall not be used to transfer biomedical waste between locations where it is contained.

(3) Compactors shall not be used in the handling of biomedical waste. Biomedical waste in bags or other disposal containers shall not be subjected to compaction by any compacting device and shall not be placed for storage or transport in a portable or mobile trash compactor.

D. Storage

(1) Biomedical waste shall be segregated from other wastes.

(2) All on-site storage of containers of biomedical waste shall be in a designated area away from general traffic flow patterns and, where possible, in a room reserved for this purpose. The manner of storage shall prevent access to or contact with such waste by unauthorized persons.

(3) Biomedical waste shall be stored in a manner that preserves the integrity of the container and is not conducive to rapid microbial growth and/or putrefaction. Pathological waste, cultures, and body parts stored for more than 24 hours after packaging in accordance with Section 12(A)(3) shall be refrigerated at a temperature of 45° F or below in a refrigerator or refrigerated space used only for biomedical waste.

(4) All areas used for the storage of biomedical waste shall be capable of being readily maintained in a sanitary condition.

(5) All biomedical waste containers must be stored in a manner that allows access for inspection.

(6) Biohazard signs shall be posted wherever biomedical waste is stored or contained, including on storage rooms doors, refrigerators, bins and other containers.

E. Manifests and Record Keeping Requirements

(1) Except as provided for in Sections 4(B) and 4(C), generators of biomedical waste that is to be transported off-site for treatment or disposal shall initiate a biomedical waste 4 part manifest available from the Department. Copy 4 of the biomedical waste manifest is to be retained by the generator; Copy 3, by the transporter; Copy 2, by the treatment, storage or disposal facility; and Copy 1 is to be returned to the generator.

(2) If the generator does not receive the completed manifest from the treatment or disposal facility within thirty-five (35) days after the date the waste was accepted by the transporter, the generator shall report this fact to the Department.

(3) Retention of Records. Manifests must be retained by the licensee for a period of not less than three (3) years. The period of retention of records is extended automatically during the course of any unresolved enforcement action regarding the regulated activity or as requested by the Commissioner. These records shall be made available for inspection by the Department upon request.

FOR A COMPLETE COPY OF THESE REGUALTIONS, PLEASE VISIT:

www.maine.gov/sos/cec/rcn/apa/06/096/096c900.doc

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